Senior/Principal Scientist - Bioassay Development
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Our team is expanding and embarking on a demanding and very exciting development journey. If you want to be part of it and have solid experience in Analytical Development, then this could be job for you! The role can be at the level of Senior Scientist, Specialist or Principal Scientist. A ranking will be performed based on the individual experience level and qualification of a suitable candidate. The position In the field of cell therapy, drug products are typically the result of long and complex in vitro differentiation protocols, which have a profound impact on the functional properties of cellular products. Development of fit-for-purpose methods and biological characterization are essential to assure adequate quality of Drug Products and implementation and control of the manufacturing process in a production plant. You will drive the development of several complex biological assays for cell-based Drug Products. Through your in-depth understanding of analytical development methodologies from the Cell Therapy or Biologics field, you will be a key player in developing and qualifying (cell-based) potency methods and other assays according to regulatory expectations. You will have limited hands-on contribution to lab work and will actively evaluate assay data for evaluation of method robustness, qualification, correlation between different platforms, and confirmation of consistency with respect to technology transfers. As subject matter expert for Analytical assays you will be involved in CMC strategies of various cell therapy solutions. Besides, you will collaborate with other departments within Cell Therapy R&D, such as Research, Quality Assurance and GMP Manufacturing. At last, your function is rounded off by your contribution to regulatory documents and meeting packages for health authorities in different geographical regions. Qualifications The ideal candidate will possess: PhD degree in Cell Biology, Biotechnology, or a similar field of studies with more than 5 years of work experience in the biotechnology or pharmaceutical industry in the area of cell therapy or Biologics. Work experience in a CMC department and / or Quality Control. A strong scientific background in cellular biology and cell culture systems. Expertise in developing cell-based (potency) assays for therapeutic Drug Products. Hands-on experience with different analytical methodologies such as Flow Cytometry, Elisa, ddPCR. A good understanding of regulatory requirements for method validation under GMP. Experience in defining specifications with respect to QTPPs. Able to analyse and interpret data using appropriate statistical models (e.g. Design of Experiments, mixed model analysis), as well as proficiency with statistical software. Working experience in international matrix organizations and Quality systems. Proficiency in English, both written and spoken. Personally, this position requires you to be a dedicated and result-oriented team player who enjoys working in innovative, international, and open-minded environment. You excel in multi-tasking, stakeholder management, can easily collaborate cross-departmentally, and are used to clearly present scientific data. About the department The department of Cell Therapy Analytics and Formulation has been established in 2020 and is part of Novo Nordisk’s Cell Therapy R&D unit, where we develop novel cell replacement therapies for the treatment of serious chronic diseases. Our department focuses on the development of Analytical methods and characterization of Cell Therapy Processes. We assure the control of manufacturing processes across the entire pluripotent stem cell workflow. Diabetes mellitus type 1, Parkinson’s disease and chronic heart failure are only some of the indications currently in the pipeline. You will join an international and dedicated Cell Therapy CMC division of ~75 employees, including scientists, project leaders and laboratory technicians. We have expertise in analytical development, bioprocess development, stem cell biology and GMP compliance and truly believe that cell therapies will make a difference in the lives of patients. If this awakens your interest, please apply and support us in translating stem cell-based products into clinical development. Working at Novo Nordisk At Novo Nordisk, your skills, dedication, and ambition help us change lives for the better for patients around the world. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Justyna Piechowska [email protected]. Deadline 12th March 2023 Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified, thus the advert may close before indicated deadline. Please attach a cover letter to your application. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 5.12.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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